和胃安神方药治疗失眠系统评价

Harmonizing Stomach and Tranquilizing Nerves Prescription in the Treating of Insomnia:A Systematic Review

目的评价和胃安神方药治疗失眠的临床疗效和安全性。方法计算机检索CNKI、万方、VIP、CBM、Cochrane Library、Embase和Medline等7个国内外中文和英文数据库,纳入中医和胃安神方药对比镇静安神类西药或临床宣教治疗失眠的随机对照试验。两位研究人员独立进行文献筛选、资料提取和纳入研究质量评价,质量评价采用Cochrane协作网偏倚风险评估工具,使用Stata 15.0进行定量分析,二分类变量采用相对危险度(RR)和95%置信区间(95%CI),连续性变量采用加权均数差(WMD)和95%CI。结果共纳入13个研究,其中1个为高质量研究,其余为低质量研究。观察组和对照组均可提高患者睡眠质量,延长睡眠时间,减少睡眠障碍。中药与艾司唑仑比较,两组疗效无差异[RR=1.269,95%CI(1.000,1.609),I^2=87.0%,P<0.001];中药与艾司唑仑和谷维素比较,两组疗效无差异[RR=1.038,95%CI(0.958,1.125)];中药和艾司唑仑合用较艾司唑仑能够更好地改善睡眠质量[RR=1.343,95%CI(1.032,1.748)];中药与地西泮比较无差异[RR=1.179,95%CI(0.998,1.392),I^2=0,P=0.668];中药、舍曲林和氯硝西泮合用较舍曲林和氯硝西泮合用能够更好地减少睡眠障碍[WMD=-1.109,95%CI(-1.941,-0.278)];中药与右佐匹克隆比较无差异[RR=1.115,95%CI(0.913,1.363)];中药和临床宣教较临床宣教能够更好地减少睡眠障碍[WMD=-2.770,95%CI(-4.041,-1.499)]。6个研究报告了不良反应,观察组205例中25例出现不良反应,对照组219例中91例出现不良反应,两组均无严重不良反应。结论中医和胃安神方药能够改善失眠患者的失眠症状,延长睡眠时间,调高生活质量,疗效优于常规西药,且安全性更好。提醒医师今后在用常规西药治疗失眠疗效不佳时,可以考虑使用和胃安神类方药。

Objective To evaluate the clinical efficacy and safety of harmonizing stomach and tranquilizing nerves prescription in the treatment of insomnia. Methods CNKI,WanFang,VIP,CBM,Cochrane Library,Embase and MEDLINE databases were retrieved by computer. They were included in the randomized controlled trials of traditional Chinese medicine(TCM)harmonizing stomach and tranquilizing nerves prescription in comparison with sedative and tranquilizing Western medicine or clinical propaganda in the treatment of insomnia. Two investigators independently performed literature screening,data extraction,and inclusion of studies quality assessments. Quality assessments were performed using Cochrane collaboration bias risk assessment tool,quantitative analysis using Stata 15.0,RR and 95% CI for the two categorical variables,and WMD=and 95% CI for the continuous variables. Results A total of 13 studies were included,one for high quality studies and the other for low quality studies. Both the observation group and the control group can improve the patients’ sleep quality,prolong sleep time,and reduce sleep disorders. Comparing TCM with estazolam,there was no difference in efficacy between the two groups [RR=1.269,95%CI(1.000,1.609),I^2=87.0%,P<0.001 ];Comparing TCM with estazolam and oryzanol,the two groups had no effect difference [RR=1.038,95%CI(0.958,1.125)];Combination of TCM and estazolam is better than estazolam in improving sleep quality [RR=1.343,95%CI(1.032,1.748)];There was no difference in TCM and diazepam [RR=1.179,95%CI(0.998,1.392),I^2=0,P=0.668];The combination of TCM,sertraline and clonazepam was better to reduce sleep disorders than sertraline and clonazepam[WMD=-1.109,95%CI(-1.941,-0.278)];There was no difference between TCM and zopiclone [RR=1.115,95%CI(0.913,1.363)];Compared with clinical education,TCM and clinical education can better reduce sleep disorders [WMD-2.770,95%CI(-4.041,-1.499)]. Adverse reactions were reported in 6 studies. Of the 205 patients in the observation group,25 had adverse reactions,and 91 of the 219 patients in the control group had adverse reactions. There was no serious adverse reactions in the two groups. Conclusion TCM harmonizing stomach and tranquilizing nerves prescription can improve insomnia symptoms in people with insomnia,prolong sleep time,improve the quality of life,and the curative effect is better than Western medicine,and the safety is better. Reminding doctors that in the future,when using conventional Western medicine to treat insomnia is ineffective,you can consider using harmonizing stomach and tranquilizing nerves prescription.